Exact Sciences lab

Exact Sciences technicians work with samples submitted for Cologuard screening tests in the Madison-based company’s specimen-processing laboratory.

The recent drop in Exact Sciences’ stock price and the Madison company’s decision not to expand Downtown have brought attention to a task force well known in medical circles but otherwise obscure.

The U.S. Preventive Services Task Force — which in October named Cologuard, Exact Sciences’ colon cancer screening test, as an alternative instead of one of the main tests recommended — wields a lot of power.

Under the Affordable Care Act, insurers must cover tests the task force recommends.

Task force decisions “immediately change clinical practice” around the country, said Dr. Pat Remington, associate dean of the UW School of Medicine and Public Health.

Exact Sciences and organizations including Mayo Clinic and the American Cancer Society have asked the panel to upgrade Cologuard, a home-based stool test, in a final determination expected next year.

But such a change is unlikely, company CEO Kevin Conroy said. “The chances are remote at best,” he said.

The task force’s Oct. 6 draft report labeling Cologuard an “alternative” sent Exact Sciences’ stock price plummeting 46 percent, to $9.98 a share from $18.53 the day before. It fell even further in the days after the announcement but has rebounded slightly since then, ending the day Monday at $9.09.

On Nov. 2, the company said it would expand at University Research Park instead of becoming a central part of the $200 million Judge Doyle Square redevelopment south of Capitol Square, leaving the project up in the air.

The Preventive Services Task Force, created in 1984 and supported by the federal government’s Agency for Healthcare Quality and Research, is made up of 16 doctors and other health professionals, including Linda Ciofu Baumann, a retired nursing professor at UW-Madison.

Members review research findings about screening tests and other preventive health measures and make recommendations for their use.

They are required to disclose financial or professional connections to topics discussed, and such conflicts of interest disqualify them from participating in related decisions, according to task force guidelines.

“They are fiercely independent,” said Remington, who added that getting named to the group is “a process that requires quite a bit of vetting.”

Remington is on another task force, supported by the Centers for Disease Control and Prevention, that evaluates community services such as diet and exercise programs to reduce the risk of diabetes.

Baumann didn’t respond to requests for comment.

Rulings influence behavior

Though the general public may not have heard of the task force, many people likely are familiar with controversial rulings it has made.

In 2012, the group recommended against prostate specific antigen (PSA) screening for prostate cancer.

“The inevitability of overdiagnosis and overtreatment of prostate cancer as a result of screening means that many men will experience the adverse effects of diagnosis and treatment of a disease that would have remained asymptomatic throughout their lives,” a task force statement said.

The American Cancer Society says men should talk to their doctors about PSA screening at age 50 or earlier if they have a high risk.

This April, a task force draft report reaffirmed its 2009 guidance about mammograms, saying women ages 50 to 74 should get the tests every two years but the decision for those in their 40s “should be an individual one.”

The cancer society says women should start annual mammograms at age 45 and switch to every two years at 55. The American College of Obstetricians and Gynecologists calls for annual mammograms starting at 40.

It’s not unusual for the task force to clarify wording in response to public comments between draft and final recommendations, but the group rarely makes substantive changes based on new evidence, said Dr. Albert Siu, task force chairman and professor at Icahn School of Medicine at Mount Sinai.

There are exceptions. In 2012, the group altered its initial stance on cervical cancer screening to say women ages 30 to 65 who want to be screened less often than three years can do a Pap smear and an HPV test every five years.

In 2013, the task force shifted its stance on hepatitis C to say doctors should not limit screening to high-risk adults but include anyone born between 1945 and 1965.

Exact Sciences hopes to add Cologuard to the list of changes. It submitted a three-part argument for why the test should be recommended along with colonoscopy or sigmoidoscopy every 10 years and two other home-based stool tests done annually.

First of all, the company said, new studies — including one on Alaska Natives — reinforce a major study last year that led the Food and Drug Administration to approve Cologuard and Medicare to cover it.

The major study, published in the New England Journal of Medicine in March 2014, said Cologuard correctly found colon cancer in 92 percent of cases, better than one of the home-based tests recommended by the task force.

Insurers still cover test

However, Cologuard had a 10 percent rate of false positives, more than double the rate for the other test, which leads to more unnecessary colonoscopies that can cause harm.

For that reason, Exact Sciences’ second point is that the task force should consider Cologuard every three years, not annually as it did in the draft report. Less frequent use increases the benefits and reduces the harm, Conroy said.

Lastly, the company said recommending Cologuard would boost colon cancer screening rates.

A CDC survey in 2010 said one in three adults ages 50 to 74 hasn’t been tested for colon cancer, which kills about 50,000 people a year, making it the second-leading cause of cancer death.

If the task force doesn’t update Cologuard next year, the next opportunity for reconsideration likely won’t be for another five to eight years, Conroy said.

Even with Cologuard’s label as an “alternative,” the test is covered by Anthem Blue Cross and Blue Shield and several other insurers, including all health plans in the Madison area.

Exact Sciences expects to complete more than 100,000 tests this year and 240,000 next year.

Dr. Gary Griglione, a gastroenterologist at Meriter Hospital, said the DNA-based Cologuard is a promising alternative for people who refuse colonoscopies.

But colonoscopies, which are much better at finding pre-cancerous polyps, likely will remain the gold standard, Griglione said.

Cologuard is “cutting edge,” he said, “but it’s almost before its time.”

[Editor's note: This story has been updated to reflect a correction. The statement that the task force may clarify wording but rarely makes substantive changes should have been attributed to Dr. Albert Siu.]

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